Director, NPD Process Improvement,

Johnson & Johnson Innovative Medicine•Warsaw, IN

2d•$164,000 - $282,900

About The Position

We are searching for the best talent to join our DePuy Synthes Orthopaedics team as a Director, NPD Process Improvement, based in West Chester, PA; Raynham, MA; Warsaw, IN; or Palm Beach Gardens, FL. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. Summary: The Director, NPD Process Improvement plays a critical strategic and operational role in creating, governing, and executing a best-in-class end-to-end process improvement strategy across Orthopaedics R&D, including GxP product development processes, R&D Business processes, and PMO operational processes for the development of implants, instruments, capital equipment, software, and biologics. This leader will be responsible for portfolio management of a comprehensive set of process improvement initiatives across R&D, optimizing and recommending the right combination and phasing of data-driven improvement projects to accelerate R&D operational performance in alignment with the company’s multi-faceted goals and in compliance with relevant regulatory standards, including FDA, ISO 13485, and 21 CFR 820. The Director will partner with critical functions such as R&D Leadership, PMO, Quality, Supply Chain, Marketing, Regulatory, Finance, and other supporting functions to ensure the process improvement portfolio roadmap is aligned and optimized to achieve long-range R&D value creation. The Director will be responsible for the results of the strategic R&D process improvement program and will drive execution per plan, demonstrating ROI for invested resources across the business. This is a high visibility role requiring significant leadership, communication, and change management, with critical input to our overall business strategy and effectiveness.

Requirements

A minimum of a Bachelor’s degree in Engineering, Science or related technical field is required.
10+ years of experience in a regulated industry environment.
Demonstrated Lean Six Sigma Black Belt certification or equivalent proven expertise/experience in Lean Six Sigma/DFSS/DMAIC as applied to R&D required.
5+ years of experience leading product development and/or process improvement / operational excellence within medical device organizations (preferred across R&D, Quality, Marketing, and/or manufacturing) with at least 5 years in a leadership/mentoring role
In-depth understanding of FDA QSR (21 CFR 820), ISO 13485, CAPA systems, and other relevant regulatory standards
5+ years experience in project / portfolio management including Agile, Scrum, and Waterfall methodologies and quantitative risk analysis methods/tools.
Strong business acumen including deep understanding of financial modeling and product development stage-gate systems or other commercialization processes
Proficiency with MS 365 Suite: (Excel, PPT, Teams, Sharepoint, OneNote, Project, Visio) required.
10% Domestic and International travel required.
Experience with geographically displaced teams required

Nice To Haves

Master’s degree preferred (MBA, MS Engineering, or related field)
Medical device industry experience is strongly preferred
Master Black Belt preferred
Experience in software and/or systems engineering strongly preferred
PMP certification preferred
CoPilot, Power BI, SmartSheet, JIRA, Planisware preferred

Responsibilities

Orthopedics R&D Process Improvement Portfolio Strategy, Execution, & Reporting: Own and direct a strategic portfolio of cross-functional process improvement projects across end-to-end R&D, ensuring they align with R&D organizational priorities and deliver measurable business value while maintaining required compliance to all regulations.
Create clear project selection criteria & ROI frameworks to ensure projects are tied to value realization (e.g. time-to-market, design cycle iteration time, software delivery efficiency, verification/validation first-pass success, cost avoidance, project governance, launch excellence, risk management, or other business objectives).
Identify and prioritize high-value process improvements spanning new product development and business processes - considering Front End, Core Development, and Post-launch activities, as well as project governance, reporting, resource management, risk management, and valuation rigor.
Gather quantitative & qualitative organizational insights to develop recommendations for how to effectively streamline.
Serve as main integrator of R&D with Cross-functions, including Quality, Regulatory, Marketing, Finance, and Supply Chain, to ensure that process improvements are effectively aligned, implemented, and sustained.
Identify, prioritize, and allocate resources needed to execute improvement initiatives in collaboration with senior leadership, balancing both strategic and operational needs and ensuring inclusion in business planning governance cycles.
Lead process improvement program execution and establish clear operating mechanisms to ensure that projects are delivering results as planned: on-time, within scope, and within budget.
Communicate and manage a large set of cross-functional stakeholders to maintain alignment as to the strategy, status, and results of the R&D process improvement portfolio.
Verify effectiveness and regularly report on the financial and operational impact of process improvements, ensuring that benefits are realized and sustained over time.
Lead change management to champion and embed desired operational behaviors across the organization.
Provide leadership with ideas for future continuous improvement, ensuring that R&D process excellence evolves in line with changing industry dynamics and best practices.
Technical Leadership & Advanced Analytics: Serve as technical authority for advanced methods and apply them effectively to manage data-driven portfolio of projects (e.g. Lean Six Sigma, DFSS, DOE, Hoshin Kanri, Failure Modes Effects, and Criticality Analysis (FMECA), Value Stream Mapping, and/or root-cause analysis).
Ensure creation & maintenance of company process maps, handoffs, and accountability maps across GxP and Business processes.
Serve as a leader on process management board to govern process changes and maintain alignment and strategic benefits of process architecture.
Recommend value-engineering approaches to manage common work such as Cases & Trays, Design Engineering, and NPI WW Expansion efforts.
Assess project management execution process efficiency and advise on best practices to senior leadership.
Strategic thinker who translates business, clinical, operational, and regulatory needs & priorities into an executable improvement agenda.
Leadership Proven ability to drive execution and deliver tangible business results in a fast-paced environment.
Demonstrated comfort with ambiguity and able to adapt quickly to changing environments Ability to supervise and inspire a team of principal engineers (Black Belts, Green Belts, or other R&D engineers), manage their performance effectiveness and support their development as future R&D leaders.
Demonstrated success in scaling continuous improvement efforts across large organizations.
Collaborative matrix leader with proven success in partnering and influencing cross-functionally.
Excellent proactive communicator: experience in executive-level stakeholder engagement, able to effectively manage expectations and simplify complex analyses for various audiences Proven versatility in diverse company sizes (small-medium and large).
Understands how to act fast with small company mentality but build sustainable processes like a corporation.
Resilient change agent who drives adoption while respecting business constraints.
Proven skills with change management leadership.
Coach and teacher who builds capability and holds high standards for technical rigor and discipline to achieve results.